System Quality Test

With latest equipments for steam quality test, for testing quality of pure steam at user point like Autoclave, Sterilizers, Manufacturing tanks, SIP, Lyophilizer, PSG etc. It is Regulatory requirement to test the quality of steam periodically. We undertake the job and provide reports which compiles to EN 285 /HTM 2010 Guidelines for Sterilizer Validation.

Test Includes,

Dryness Value Test

Superheat Value Test

Condensable Gases Test

Comp. Air Validation

Compressed Air Validation & Nitrogen Air Validation

Compressed Air Validation, a very essential confiendence requirement for using the compressed air in production areas, we have latest set of equipment to carry test as per ISO 8573 guidelines. It is Regulatory requirement to test the quality of steam periodically.

Test Includes,

Non Viable Particle Count Test

Dew Point Temperature

OilContent

Moisture Content

Nitrogen Oxide

Hydrogen Sulphide

Sulpher Dioxide

Carbon Monoxide

Carbon Dioxide

Water Vapour

OilMist

Nitrogen Air Validation

PLC Validation

All computer systems and software impacting on product quality must be identified, and the risks in their use evaluated. From large-scale process control through to simple embedded code in a regulated device, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems.

Validation can increase the usability and reliability of the system, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to customers and users.

We ensure that your computer systems are compliant with GAMP 5,FDA, GxP, 21 CFR Part 11,EU Annex 11,organizational quality system (GLP, GMP, and GCP) Other Governmental regulations and industry standards.